Pfizer, Moderna Covid Vaccines Are Effective In Young Children, FDA Says—Here’s How They Differ And What Happens Next

Topline

Three doses of Pfizer’s vaccine and a two-doses of Moderna’s shot are safe and effective in preventing illness from Covid-19 in young children, according to assessments provided by the Food and Drug Administration, in a possible signal that the agency is gearing up to approve Covid vaccinations for the youngest Americans later this week.

Both the Pfizer and Moderna Covid-19 vaccines may be approved for emergency use in the U.S. among … [+] children under the age of five later this week.

Los Angeles Times via Getty Images

Key Facts

In a briefing document published on Sunday, the FDA said the three doses appeared to be 80.4% effective in preventing illness in the age group.

In its assessment, the FDA noted the available data supported the effectiveness of Pfizer’s three-dose regimen in preventing Covid illness in children under the age of five.

In a similar assessment released on Friday, the drug regulator found two doses of Moderna’s vaccine to be safe and effective for use in children under the age of six.

Moderna’s two doses reported a much lower 50.6% efficacy in preventing illness.

A key caveat in the Pfizer findings was that only 10 participants—eight in the placebo group and two in the vaccinated group—reported illness during the trial, which is below the threshold required to accurately determine efficacy.

Additionally, the efficacy may not be directly comparable as the vaccine trials were carried out during different times.

Tangent

Both Pfizer and Moderna have taken different approaches to their vaccines for young children. Pfizer’s inoculation uses three shots each with a tiny 3 μg (micrograms) dose, which is a tenth of the size of the doses administered to adults. Moderna’s vaccine for young children and infants uses two 25 μg doses, which is a quarter of the dosage given to adults. The second Pfizer dose is administered three weeks after the first and is followed by a third shot at least eight weeks after the second. The two Moderna doses are administered 28 days apart.

What To Watch For

An independent panel of experts is set to meet and analyze data from both vaccine makers on Wednesday after which it will provide its recommendation to the FDA. Shortly after Wednesday’s meeting, the FDA is expected to announce its official decision on a possible emergency use authorization of the two shots for the youngest group of Americans. The New York Times, citing public health experts, reports that shots from both makers may be approved to offer parents a choice of vaccine for their children. The Centers for Disease Control and Prevention is also expected to provide its recommendations after convening its own independent panel after the FDA’s decision.

Key Background

Last week, anticipating FDA approval, the Biden administration outlined its vaccination plan for children under the age of five, which included ordering 10 million additional vaccine doses to specifically serve children in the age group. The White House said it was prepared to roll out the vaccines by June 20, if their usage is approved both by the FDA and CDC this week. After the initial tranche of 10 million doses, the White House expects to make millions more available in subsequent weeks. In addition to delivering the vaccine doses, the White House plans to make authoritative and trustworthy information about the vaccines more easily available to parents to inform them about “the importance of getting their children vaccinated.” According to a Kaiser Family Foundation (KFF) poll conducted in April, only 18% of parents plan to vaccinate their young children immediately after the shots are approved, with 38% deciding to take a wait-and-watch approach.

Surprising Fact

The omicron wave led to a four-fold increase in hospitalization among children, despite the belief that the fast-spreading variant causes less severe disease. Children under five—who are not eligible for vaccination—witness the steepest rise with 15.6 weekly hospitalizations per 100,000 children compared to just 2.9 during the previous wave caused by the delta variant.